• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM- ARTICULAR SURFACE FIXED BEARING PROSTHESIS, KNEE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER, INC. ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM- ARTICULAR SURFACE FIXED BEARING PROSTHESIS, KNEE Back to Search Results
Catalog Number 42512200611
Device Problem Difficult to Insert (1316)
Patient Problem No Information (3190)
Event Date 06/19/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The following report is submitted to relay additional information. Concomitant medical products: femur cemented cruciate retaining (cr) standard left size 10 lot# 62575604. Item# 42502606801, tibia cemented 5 degree stemmed left size g lot# 63404221 item# 42532007901, all-poly patella cemented 35 mm diameter lot#63538185 item# 42540200035, articular surface fixed bearing ultracongruent (uc) left 11 mm height lot# 63044556 item# 42512200611, 2. 5 mm female hex screw 25 mm length lot# 63649495 item# 42509902525. The reported event could not be confirmed based on limited information received. No products were returned; therefore, the visual and dimensional inspections were not performed. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required. Compatibility check noted no issues. A definitive root cause cannot be determined with the information provided. No corrective actions, preventive actions, or field actions resulted after investigation of this event. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Visual evaluation of the returned articular surface show that the device is nicked and gouged on both the superior and inferior side. Additionally, the dovetail feature is flared all around. Dimensions of the medial lateral width, anterior-posterior medial condyle width, and anterior-posterior lateral condyle width were measured and were found to be within print specifications. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required. A definitive root cause cannot be determined with the information provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
(b)(4). (b)(4). (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Product expected, not yet received.
 
Event Description
It was reported that the surgeon was unable to get the articular surface to engage with the tibial baseplate despite following the surgical technique. Surgery was delayed by ten to fifteen minutes while a replacement item was delivered. Attempts have been made and no further information has been provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM- ARTICULAR SURFACE FIXED BEARING
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6716612
MDR Text Key248904564
Report Number0001822565-2017-04878
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
PK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue Number42512200611
Device Lot Number62932150
Other Device ID NumberSEE NARRATIVE IN H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/17/2017 Patient Sequence Number: 1
Treatment
UNKNOWN PERSONA TIBIAL TRAY
-
-